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Uncemented Total Elbow Arthroplasty Data Collection

This study is currently recruiting participants.
Verified February 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00974298
First received: September 2, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to document the performance and clinical outcomes of uncemented total elbow replacements involving the press-fit technique performed at the Vanderbilt Hand Center. The press-fit use technique is often used because of complications with cement loosening.


Condition Intervention
Total Elbow Arthroplasty
 Procedure: Total elbow replacement arthroplasty

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Uncemented Total Elbow Arthroplasty Data Collection

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Patient examination measurements and radiographic measurements will be used to determine the effects of an uncemented total elbow arthroplasty [ Time Frame: Pre-operative to five year post-operative appointment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elbow replacement
There are no other arms other then an uncemented total elbow replacement.
 Procedure: Total elbow replacement arthroplasty
Total elbow arthroplasty using pressfit technique in which no cement is used.

Detailed Description:

The three parts of this study will be:

Retrospective Chart Review-

A chart review will be completed on all patients that have had an uncemented total elbow arthroplasty using the press-fit technique at Vanderbilt Hand & Upper Extremity Center. The chart review will include:

  • A historical data form
  • An operative data form
  • A radiographic assessment form

Questionnaire Mailing- We will mail prospective study patients a DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire to complete with a mailing letter explaining the request for this information. The DASH will be modified to ask patients regarding their pre-operative time as well.

Clinical Data Collection-

We will enroll patients who have already had/or will be having a uncemented total elbow arthroplasty using the press-fit technique. If the patient already has a file completed through the chart review we will not complete the historical data form, operative form, or previous radiograph assessments. If the patient does not have a file completed through the chart review the data collection will include:

  • An Informed Consent Document
  • A historical data form
  • An operative data form
  • A radiographic assessment form
  • Patient-completed DASH questionnaire
  • Elbow Assessment Form
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who require total elbow arthroplasty.

Criteria

Inclusion Criteria:

  • Any patient who has had a total elbow arthroplasty using a press-fit technique at the Vanderbilt Hand & Upper Extremity Center

Exclusion Criteria:

  • Patients less than 18 years old
  • For chart review and post-operative enrollment the patients must have adequate radiographs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974298

Contacts
Contact: Julie M Daniels, BBA 6153224506 Julie.M.Daniels@Vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Hand & Upper Extremity Center Recruiting
Nashville, Tennessee, United States, 37232-8828
Principal Investigator: Donald H Lee, MD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Donald Lee, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Donald Lee, Professor of Orthopaedic Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00974298     History of Changes
Other Study ID Numbers: 090342
Study First Received: September 2, 2009
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013